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Posts Tagged ‘GAMP’

Designing and Building Pharmaceutical and Biotech Smart Factories

Posted in Life Sciences, Operations Management on Wednesday, February 7th, 2018. No comments yet
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Pharmaceutical and biotech manufacturers seek to improve both project and operational performance through implementation of smart factory technology. The smart factory fits right into the S95 enterprise automation model and provides out-of-box manufacturing functionality representing the best practice in the industry and complying with the regulation such as cGMP. The smart factory technology connects the […]

CPhI Pharma Evolution Guest Post-Electronic Batch Records: Are Your Systems Ready for Inspection?

Posted in Life Sciences, Operations Management, Regulatory Compliance on Thursday, May 23rd, 2013. 3 comments so far
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I wanted to share my guest post published at the CPhI Pharma Evolution website. There are some great comments, so join in if the post sparks some ideas. Stringent inspection-readiness policies are common with pharmaceutical and biotech manufacturers. From a computerized system standpoint, the rules of Part 11 (Electronic Records; Electronic Signatures – Scope and […]